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This is a multicenter, randomised phase II trial in patients with high risk GCT.

Primary objective:

Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high risk' GCT as compared to standard care

Secondary objectives:

Determine the relapse free survival

Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT

Condition or disease

Intervention/treatment

Phase

Giant Cell Tumor of BoneOsteoclastoma

Drug: Zoledronic acid

Phase 2

Detailed Description:

GCT is a potentially malignant tumour that presents with a locally destructive osteolytic lesion. The high risk GCT are characterized by a high recurrence rate around the 40-45%. Zoledronic acid is a potent inhibitor of osteolysis and is capable of inducing osteoclast and stromal cell apoptosis, which makes it an attractive adjuvant treatment in 'high risk' GCT in order to improve clinical outcomes and reduce the recurrence rate.

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Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Signed written informed consent

Male or female > 18 years of age

Histologically proven GCT treated with surgery

High risk GCT defined as minimal one or more of the following:

Recurrent GCT

GCT located in the pelvis, sacrum, spine, distal ulna or growth in soft tissue

GCT grade III

Pathological fracture in GCT

Absence of local adjuvant therapy (cryosurgery or phenol instillation)